Short answer
Beta Bionics, Inc. (BBNX) filed its Q2 2026 10-Q quarterly report on Jul 29, 2026 for the quarter ended Jun 30, 2026. Quarterly revenue was $32M (up 37.8% year over year) with net income of −$23M.
Q2 2026 key financials · XBRL
- Revenue
- $32M
- +37.8% YoY · +15.9% QoQ
- Net income
- −$23M
- −38.7% YoY · −6.9% QoQ
- Operating margin
- -79.9%
- Gross margin
- 59.0%
- EPS (diluted)
- −$0.53
- −76.7% YoY · −8.2% QoQ
Source: XBRL data from the Beta Bionics, Inc. (BBNX) Q2 2026 10-Q on SEC EDGAR. USD.
Beta Bionics, Inc. Q2 2026 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Six-month PBP sales 37% vs 21% YoY; quarterly revenue and dollar change not provided
- MDI adoption 69% vs 71% YoY during six months ended June 30
- PBP channel generated initial negative gross margin; cumulative positive gross margin expected after third month
- $4.0M paid toward up to $5.1M additional Phase 3 development and manufacturing costs
- FDA Warning Letter cited Quality Management System, Medical Device Reporting, and Correction and Removals deficiencies
Risk Factors
- Newly effective QMSR requirements from February 2, 2026, incorporating ISO 13485:2016 and potentially increasing compliance costs
- Most material regulatory update: January 29, 2026 FDA Warning Letter citing Quality Management System, Medical Device Reporting, and Corrections and Removals deficiencies
- FDA post-market surveillance order for iLet, with potential recalls or field withdrawals if safety or performance concerns emerge
- Mint commercialization targeted by end of second quarter 2027, subject to FDA 510(k) clearance and manufacturing scale-up
- Business concentration in iLet, the company’s only commercial product for T1D in adults and children six years and older
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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